The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron Onestep Aptt Test.
| Device ID | K915344 |
| 510k Number | K915344 |
| Device Name: | HEMOCHRON ONESTEP APTT TEST |
| Classification | Activated Partial Thromboplastin |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Contact | Matt Lesnieski |
| Correspondent | Matt Lesnieski INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-26 |
| Decision Date | 1992-02-11 |